Differences on product labels of compounders and conventional manufacturers may lead to dosing errors

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October 1, 2018

Differences on product labels of compounders and conventional manufacturers may lead to dosing errors

FDA has received reports of dosing errors and confusion with the labeled strength expression for certain compounded injectable products.

FDA has received reports of dosing errors and confusion with the labeled strength expression for certain compounded injectable products. Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently. Additionally, FDA has received multiple complaints raising concerns that displaying the strength per milliliter in larger, more prominent font, instead of the strength per total volume, may lead to confusion about how much drug is in the container. Dosing errors could be avoided for small volume parenteral products, by expressing the drug strength per total volume as the primary and prominent expression on the principal display panel of the label, followed in close proximity by strength per milliliter enclosed by parentheses. Labeling compounded injectables using the strength convention adopted by conventional manufacturers could avoid confusion and reduce the risk of medication errors. Because labels of compounded products are not reviewed by FDA prior to marketing, health care professionals should be vigilant when administering compounded products to patients to avoid confusion and ensure that each patient is administered the prescribed dose of the intended drug. Health care professionals may consider requesting compounders to label products with the strength per total volume as the primary and prominent expression on the principal display panel of the label, followed in close proximity by strength per milliliter enclosed by parentheses to minimize the risk of errors.